JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02)— 510(k) K090856

Substantially Equivalent

Thyssenkrupp Ceteco Srl

FDA 510(k) clearance K090856 for JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02), Substantially Equivalent on 2009-05-27. Applicant: Thyssenkrupp Ceteco Srl.

Clearance details

Applicant: Thyssenkrupp Ceteco Srl
Product code: Code ING
Advisory panel: Physical Medicine
Date received: 2009-03-30
Decision date: 2009-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pisa, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code ING

product code ING

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.